Increasing Physical Activity Through Social Support and Stress Resilience

Not Applicable

Not yet recruiting

• Conditions: Healthy; Social Isolation in Older Adults; Subjective Cognitive Decline (SCD); Sedentary Behavior

• Registration Number: NCT06896825
• Lead Sponsor: Arizona State University

Brief Summary

The goal of this clinical trial is to learn the effects of technology enhancements when combined with basic education, goal-setting, and self-monitoring to increase physical activity among older adults living alone, experiencing subjective cognitive decline, and currently engaging minimal physical activity (60 minutes or less of moderate to vigorous physical activity). Further, we will examine key psychosocial mechanisms believed to contribute to successful promotion of physical activity, which include social support and stress resilience.

The primary questions are to determine whether

* the tech-enhanced condition lead to greater physical activity over time?

* the tech-enhanced condition lead to social support and stress resilience over time?

* social support and stress resilience mediate the relationship between the study condition and physical activity?

All participants will engage in self-monitoring of physical activity, will receive weekly text reminders of their physical activity goals for the week, and will receive basic education about the importance of physical activity, social support, and stress resilience for cognitive, physical, and psychological health. Participants in the tech-enhanced condition will also receive access to a study-specific website and virtual coaching to reinforce the information presented. Researchers will then compare the tech-enhanced condition to the basic education condition to determine the benefits of technology to deliver the intervention materials in order to increase physical activity, social support, and stress resilience.

Participants will:

* Use a Garmin wearable device to monitor their physical activity

* Be randomly assigned to a basic education condition or tech-enhanced condition

* Set achievable goals for weekly physical activity, with incremental increases to achieve 150 minutes per week by the end of the study

* Respond to surveys to monitor their social support, stress resilience, quality of life, and depression.

The sample has several risk factors for Alzheimer's disease and related dementias: low physical activity, social isolation risk via living alone, and subjective cognitive impairment. Therefore, a long-term goal includes the determination of the intervention's effectiveness at increasing physical activity, social support, and stress resilience to reduce risk for developing dementia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-26
• Last Update Posted: 2025-03-26
• Study Start: 2025-04
• Primary Completion: 2026-05
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Aged 60 years or older
• Living alone and community dwelling
• Engaging in 60 minutes or less per week of self-reported moderate-to-vigorous physical activity at screening (based on Exercise Vital Sign Questionnaire)
• Self-reported decline in cognitive functioning
• Self-reported ownership of/willingness to use a smartphone with an iOS or Android operating system (necessary for participants to track their activity using a wearable activity monitor).
• Able to read and speak in English. We hope to offer the intervention in Spanish in the future; however, currently, the study materials are only available in English, and participation will require ability to read and respond to study materials.

Exclusion Criteria

• Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a physician's note is provided
• Resting blood pressure greater than 200/110 mmHG as assessed at the baseline study assessment (unless a physician's note is provided)
• Plans to relocate out of metropolitan Phoenix, Arizona area in the next 6 months
• Participation in another physical activity, nutrition or weight loss program at time of screening or at any time during the intervention
• Individuals with mild cognitive impairment (MCI), as determined by either a self-report of receiving a diagnosis of MCI from a health care provider or as assessed by the Telephone-Montreal Cognitive Assessment (T-MoCA) at the Baseline Session. A score < 19 is an exclusion criterion.
• Individuals with neurodegenerative (e.g., dementia), developmental (e.g., autism), neurologic (e.g., Parkinson's, epilepsy), or major psychiatric (e.g., bipolar, schizophrenia) diagnoses
• Being previously prescribed one of the 5 approved Alzheimer's medications, including: Donepezil (Aricept), Rivastigmine (Exelon), Galantamine (Razadyne), Memantine (Namenda), Memantine + Donepezil (Namzaric)
• Score of 9 or higher on the 15-item Geriatric Depression Scale (GDS) at the Baseline Session [scores of 9 and higher are indicative of moderate to severe depression]
• Currently taking 2 or more anti-depression medications
• History of stroke
• Incarcerated individuals (i.e., Prisoners)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in accelerometer-measured moderate to vigorous physical activity	One week at baseline and one week after intervention concludes	ActiGraph GT9X Link Activity monitors worn on non-dominant wrist during waking hours 7 consecutive days will provide objective baseline of moderate to vigorous activity prior to and after the intervention. GTX9X data (collected in raw format) will be aggregated for analysis to epochs of 60 secs or less for comparability to other studies.
Change in Garmin-assessed physical activity	From enrollment to the end of treatment at 3 months	Participants agree to wear a Garmin throughout the study, offering continuous data about their physical activity. 'Intensity Minutes' is Garmin's measure of moderate to vigorous physical activity; we will use weekly Intensity Minutes (Monday to Sunday) to assess physical activity continuously during the intervention.
Change in self-reported physical activity	Reported at baseline and after the 3 month intervention	Participants will complete an abbreviated 7-Day Physical Activity Recall interview, which assesses self-reported moderate to vigorous physical activity.

Secondary Outcome Measures

Name	Time	Method
Self-reported stress	Assessed at baseline, end of month 1, end of month 2, and end of month 3	The 14-item Perceived Stress Scale, with items rated on a 5 point scale. Means scores are calculated, such that higher scores indicate greater perceived stress.
Objective Stress Resilience	Assessed at baseline and after the 3 month intervention	At baseline and 3 months, participants will have blood drawn to assess glial fibrillary acidic protein, an indicator of stress which has also been associated with dementias.
Brief Resilience Scale	Assessed at baseline, end of month 1, end of month 2, and end of month 3	The 6-item Brief Resilience Scale assesses ability to recover from or adjust to challenges. Items are rated on a 5 point scale. Mean scores are calculated, with higher scores indicating greater resilience.
Social Isolation	Assessed at baseline, end of month 1, end of month 2, and end of month 3	The 10-item Lubben Social Network Scale assess objective size of social network. Items are rated on a 6 point scale. Sum scores are calculated, and higher scores indicate larger social network and contacts.
Self-reported loneliness	Assessed at baseline, end of month 1, end of month 2, and end of month 3	The 3-item UCLA Loneliness scale assesses the feeling of being alone or lacking companionship. Responses range from 1 to 3. Sum scores are calculated, and higher numbers indicate greater sense of loneliness.
Objective cognitive functioning: Visual memory	Assessed at baseline and after the 3 month intervention	Participants will complete a visual memory task in which they see a series of pictures in a specified order. Immediately after, they are tasked with placing the pictures in the correct order. This is the Picture Sequence Memory Test from the NIH Toolbox Cognitive Battery. Scoring is automatically calculated by the NIH Toolbox App and is age normed, with higher scores indicating stronger performance on the task.
Objective cognitive functioning: Verbal memory	Assessed at baseline and after the 3 month intervention	Participants will complete a verbal memory task in which they hear a series of words read and are asked to recall as many as they can immediately after the list; this process is completed three times total to assess both learning and memory. Ten to 15 minutes later, they are asked to recall as many words as possible. This is the Auditory Verbal Learning Test from the NIH Toolbox Cognitive Battery. Scoring is automatically calculated by the NIH Toolbox App and is age normed, with higher scores indicating stronger performance on the task.
Objective cognitive functioning: Executive functioning	Assessed at baseline and after the 3 month intervention	Participants will complete an executive functioning task requiring set-shifting, or the ability to switch back and forth between multiple aspects of a strategy or task. This is the Dimensional Change Card Sort Task from the NIH Toolbox Cognitive Battery. Scoring is automatically calculated by the NIH Toolbox App and is age normed, with higher scores indicating stronger performance on the task.
Objective cognitive functioning: Processing Speed 1	Assessed at baseline and after the 3 month intervention	Participants will complete two tasks assessing processing speed. The first requires visual processing of patterns in two pictures, detecting similarities and differences as quickly as possible without making mistakes. This is the Pattern Comparison Task from the NIH Toolbox Cognitive Battery. Scoring is automatically calculated by the NIH Toolbox App and is age normed, with higher scores indicating stronger performance on the task.
Objective cognitive functioning: Processing Speed 2	Assessed at baseline and after the 3 month intervention	Participants will complete two tasks assessing processing speed. The second requires matching of patterns between numbers and symbols as quickly as possible without making mistakes. This is the Oral Symbol Digit Task from the NIH Toolbox Cognitive Battery. Scoring is automatically calculated by the NIH Toolbox App and is age normed, with higher scores indicating stronger performance on the task.
Depression	Assessed at screening and after the 3 month intervention	Participants will complete the 15-item Geriatric Depression Scale. The items include yes/no responses. Scores will be summed, such that higher scores indicate greater depression. At eligibility screening, participants must score below 9 on this measure to be included in the study.
General Anxiety	Assessed at baseline, end of month 1, end of month 2, and end of month 3	Participants will complete the 7-item General Anxiety Disorder Questionnaire. Using a 4 point scale, the items assess worry and anxiety over the past two weeks. Mean scores will be calculated, such that higher scores indicate greater anxiety.
Health-related quality of life	Assessed at baseline, end of month 1, end of month 2, and end of month 3	Participants will complete the 4-item health-related quality of life assessment. The items assess self-perceived health and days during the past month they had poor physical health or mental health, and the extent to which poor health kept them from doing daily activities. Mean scores will be calculated, such that higher scores poorer health-related quality of life.

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Phoenix, Arizona, United States